Edwards Lifesciences Senior Manufacturing Engineer, Tissue Processing and Technologies in Irvine, California
The Tissue Process Engineering Group (TPEG) in Technical Operations is responsible for the design, development, and implementation of next-generation manufacturing technologies and processes including laser micromachining, solutions system development, automated inspection and 3D measurement solutions, and end-to-end automation of manufacturing processes. In this highly visible role, the Senior Engineer would be responsible for leading large, complex engineering projects which impact Irvine, Singapore and Costa Rica manufacturing plants.
Partner with tissue and Automation SMEs / external vendors to design and implement complex engineering solutions for bovine pericardial tissue manufacturing used in the manufacture of bioprosthetic heart valves.
Lead the transfer of projects to global sites as needed (Singapore, Costa Rica).
Lead and establish complex project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.).
Establish effective communication channels for a wide network of stakeholders and frequently present to leadership forums.
Apply Six Sigma DMAIC methodology to reduce process variability and improve cost/reliability.
Apply Lean engineering principles to evaluate value streams, develop process maps, design manufacturing line layouts, and diagnose flow problems (can partner with Business Excellence team and learn on the job).
Identify and ensure implementation of opportunities to optimize/improve manufacturing processes using engineering methods.
Develop complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports.
Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes.
Perform other duties and responsibilities as assigned.
Bachelor's Degree in Engineering or Scientific field with 4 years of manufacturing engineering experience OR Master’s Degree in Engineering or Scientific field with 3 years of manufacturing experience.
Travel Requirements are up to 20% during transfers.
Six Sigma related certifications are preferred.
Experience developing and implementing automated solutions in medical device space.
Experience working with laser micromachining, solutions system development, or chemical processing.
Developing detailed process maps, identifying opportunities for improvement, and driving results in collaboration with key cross-functional stakeholders (Microbiology, Chemistry, Tissue R&D, Quality).
Strong technical skillset in the area of manufacturing engineering: design for manufacturability (DFM), EH&S guidelines, FDA guidelines, and process validation.
Ability to draft Technical Summaries justifying changes to existing processes.
Proven successful project management skills for process/technology transfer.
Excellent problem-solving, organizational, analytical and critical thinking skills.
Effective communication and interpersonal skills at all levels of employees, suppliers, and consultants.
Proven expertise in Microsoft Office Suite and manufacturing systems.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.